August23,2022-The World Health Organization (WHO) ranked China's vaccine regulatory system at a functional level of maturity according to the WHO's global classification system for national medical product regulatory authorities, which experts said means that China has a stable, well-functioning and integrated regulatory system to ensure the quality, safety and efficacy of vaccines that are manufactured, imported or distributed in the country, and lays an important foundation for Chinese vaccines to be imported by other countries.
The WHO confirmed the Chinese National Regulatory Authority's (NRA) attainment of maturity level three (ML3) - the third of four levels in the WHO's classification. Maturity level four (ML4) is the highest.
“I believe this achievement will further prompt other countries in the Western Pacific Region to invest in strengthening regulatory systems to ensure the availability and access to quality, safe, effective, and affordable medical products to their peoples. It should also serve to promote confidence, trust, and further reliance on authorities attaining this level of maturity,” said Mariângela Simão, WHO Assistant Director-General for Access to Medicines and Health Products.
“WHO’s conclusion on China’s vaccine regulatory system is solid proof that our system is continuously stable, effective and well-functioning, and it is capable of making more contributions to the global supply by providing safe, effective, affordable and accessible vaccine products with high quality,” said Jiao Hong, Commissioner of the National Medical Products Administration (NMPA), China.
WHO performed an assessment of the Chinese National Regulatory Authority (NRA) in April 2014, based on the then WHO vaccines assessment tool indicators and focusing on the Chinese vaccine regulatory system and performed additional benchmarking activities in 2019 and 2021. As a follow up to these activities, a WHO expert team conducted the formal benchmarking of the Chinese NRA, represented by NMPA, in July 2022 using an updated and more comprehensive assessment tool, theWHO Global Benchmarking Tool. During the benchmarking, WHO noted that the NMPA had considered and addressed recommendations made following the activities in 2014, 2019 and 2021, confirming the country’s ML3 achievement for the regulation of vaccines in China.